A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CEFEPIME- AAI101 COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS

Allecra Therapeutics SAS,0 个研究点目标入组 20 人开始时间: 2018年11月6日最近更新: 2023年9月4日

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•1. Male or female patients >= 18 years of age at the time of signing of informed consent;
•2. Expectation that the patient’s cUTI or AP will require hospitalization and initial treatment with
•at least 7 days of intravenous (i.v.) antibiotics;

•1. Known urine culture with Gram-positive primary pathogen at 105 colony-forming units
•(CFU)/mL (not contaminant) or suspected Gram-positive pathogen by Gram staining
•(Note: Gram staining is optional);
•2. History of significant hypersensitivity or allergic reaction to cefepime,
•piperacillin/tazobactam, any of the excipients used in the respective formulations, any
•beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams), or
•any beta-lactamase inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid);

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